Escolar Documentos
Profissional Documentos
Cultura Documentos
Internationally harmonised
Dalteparin Sodium
*
Danaparoid Sodium
*
Enoxaparin Sodium
*
Bovine Insulin
*
Human Insulin
*
Porcine Insulin
*
Parnaparin Sodium
*
Tinzaparin Sodium
*
Injectable Insulin Preparations
*
Insulin Injection
*
Biphasic Insulin Injection
*
Biphasic Isophane Insulin Injection
*
Isophane Insulin Injection
*
Protamine Zinc Insulin Injection
Insulin Zinc Suspension
*
Insulin Zinc Suspension (Amorphous)
*
Insulin Zinc Suspension (Crystalline)
*
Appendix XIV J. Blood and Related
Products
Appendix XXI B. Approved Synonyms
Veterinary Vaccines
*
Porcine Actinobacillosis Vaccine,
Inactivated
*
Porcine Enzootic Pneumonia Vaccine
(Inactivated)
*
Porcine E. Coli Vaccine, Inactivated
*
Porcine Parvovirus Vaccine, Inactivated
*
Porcine Progressive Atrophic Rhinitis
Vaccine, Inactivated
*
Swine Influenza Vaccine, Inactivated
*
Appendix XV K (Vet) 3. Evaluation of
Safety of each Batch of Veterinary
Vaccines and Immunosera
Appendix XXI B (Vet). Approved
Synonyms
Internationally harmonised
Human Insulin
*
Anthrax Vaccine for Human Use (Adsorbed, Prepared
from Culture Filtrates)
*
Bacillus Calmette-Guérin Vaccine
*
Cholera Vaccine
*
Cholera Vaccine, Freeze-dried
*
Adsorbed Diphtheria Vaccine
*
Pneumococcal Polysaccharide Vaccine
*
Smallpox Vaccine (Live)
*
Typhoid Vaccine
*
Typhoid Vaccine, Freeze-dried
*
Yellow Fever Vaccine, Live
*
Old Tuberculin
*
Tuberculin Purified Protein Derivative
*
Appendix XIV G. Test for Histamine
Appendix XIV J. Blood and Related Products
Appendix XIV K. Immunological Products
Appendix XVI B. Microbiological Examination of Non-
sterile Products
SC IV G. 5. Examples
Anthrax Vaccine, Living
*
Aujeszky's Disease Vaccine, Inactivated
*
Aujeszky's Disease Vaccine, Living
*
Canine Parvovirus Vaccine, Inactivated
*
Clostridium Chauvoei Vaccine
*
Clostridium Tetani Vaccines
*
Equine Influenza Vaccine, Inactivated
*
Feline Infectious Enteritis Vaccine, Inactivated
*
Bovine Leptospirosis Vaccine (Inactivated)
*
Porcine Actinobacillosis Vaccine, Inactivated
*
Porcine Enzootic Pneumonia Vaccine
(Inactivated)
*
Porcine E. Coli Vaccine, Inactivated
*
Porcine Parvovirus Vaccine, Inactivated
*
Porcine Progressive Atrophic Rhinitis Vaccine,
Inactivated
*
Swine Erysipelas Vaccine, Inactivated
*
Swine-Fever Vaccine (Live, Prepared in Cell
Cultures), Classical
*
Swine Influenza Vaccine, Inactivated
*
Avian Tuberculin Purified Protein Derivative
*
Bovine Tuberculin Purified Protein Derivative
*
*
European
Internationally harmonised
Part II
Substances for Pharmaceutical Use
*
Allergen Products
*
Aluminium Stearate
*
Botulinum Toxin Type A for Injection
*
Botulinum Toxin Type B for Injection
*
Bovine Serum
*
Cetostearyl Alcohol
*
Cetyl Alcohol
*
Chondroitin Sulfate Sodium
*
Chorionic Gonadotrophin
*
Diethylene Glycol Palmitostearate
*
Erythropoietin Concentrated Solution
*
Ethylene Glycol Monopalmitostearate
*
Products of Fermentation
*
Glycerol Distearate
*
Glycerol Mono-oleate
*
Glycerol Monostearate 40-55
*
Heparin Calcium
*
Heparin Sodium
*
Substances for Pharmaceutical Use
*
Macrogol Oleate
*
Magnesium Stearate
*
Menotrophin
Oleic Acid
*
Oleyl Alcohol
*
Palmitic Acid
*
Propylene Glycol Monopalmitostearate
*
Products of Recombinant DNA Technology
*
Sorbitan Oleate
*
Sorbitan Sesquioleate
*
Sorbitan Trioleate
*
Products with Risk of Transmitting Agents of Animal Spongiform
Encephalopathies
*
Squalane
*
Stearic Acid
*
Stearyl Alcohol
*
Urofollitropin
*
Vitamin A
*
PARENTERAL PREPARATIONS
*
TOPICAL SEMI-SOLID PREPARATIONS
*
Unlicensed Medicines
Chorionic Gonadotrophin Injection
Erythropoietin Injection
Injectable Insulin Preparations
*
Herbal Drugs
*
EXTRACTS
*
Homoeopathic Preparations
*
Herbal Drugs for Homoeopathic Preparations
*
Methods of Preparation of Homoeopathic Stocks and Potentisation
*
GREY LISTS (MASBOOH): ANIMALS,
HUMAN, INSECTS, OTHERS..2
Mother Tinctures for Homoeopathic Preparations
*
Monoclonal Antibodies for Human Use
*
Immunosera
*
Anti-T Lymphocyte Immunoglobulin for Human Use, Animal
*
Diphtheria Antitoxin
*
Tetanus Antitoxin
*
VACCINES
*
Anthrax Vaccine for Human Use (Adsorbed, Prepared from Culture Filtrates)
*
Bacillus Calmette-Guérin Vaccine
*
BCG for Immunotherapy
*
Adsorbed Diphtheria Vaccine
*
Diphtheria Vaccine (Adsorbed, Reduced Antigen Content)
*
Adsorbed Diphtheria and Tetanus Vaccine
*
Diphtheria and Tetanus Vaccine (Adsorbed, Reduced Antigen(s) Content)
*
Diphtheria, Tetanus and Hepatitis B (rDNA) Vaccine (Adsorbed)
*
Diphtheria, Tetanus and Pertussis (Whole Cell) Vaccine (Adsorbed)
*
Adsorbed Diphtheria, Tetanus and Pertussis (Acellular Component) Vaccine
*
Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Haemophilus
Type b Conjugate Vaccine
*
Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Hepatitis B
(rDNA) Vaccine
*
Adsorbed Diphtheria, Tetanus, Pertussis (Acellular Component) and Inactivated
Poliomyelitis Vaccine
*
Diphtheria, Tetanus and Poliomyelitis (Inactivated) Vaccine (Adsorbed, Reduced
Antigen(s) Content)
*
Diphtheria, Tetanus, Pertussis (Acellular, Component) and Poliomyelitis (Inactivated)
Vaccine (Adsorbed, Reduced Antigen(s) Content)
*
Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated) and
Haemophilus Type b Conjugate Vaccine (Adsorbed)
*
Diphtheria, Tetanus, Pertussis (Acellular, Component), Hepatitis B (rDNA),
Poliomyelitis (Inactivated) and Haemophilus Type b Conjugate Vaccine (Adsorbed)
*
Diphtheria, Tetanus, Pertussis (Whole Cell), Poliomyelitis (Inactivated) and
Haemophilus Type b Conjugate Vaccine (Adsorbed)
*
Diphtheria, Tetanus, Pertussis (Whole Cell) and Poliomyelitis
(Inactivated) Vaccine (Adsorbed)
*
Haemophilus Type b Conjugate Vaccine
*
Inactivated Hepatitis A Vaccine
*
Hepatitis A Vaccine (Inactivated, Virosome)
*
Hepatitis B Vaccine (rDNA)
*
Influenza Vaccine (Whole Virion, Inactivated, Prepared in Cell
Cultures)
*
Influenza Vaccine (Surface Antigen, Inactivated, Prepared in Cell
Cultures)
*
Measles Vaccine, Live
*
Mumps Vaccine, Live
*
Pertussis Vaccine (Whole Cell, Adsorbed)
*
Adsorbed Pertussis Vaccine (Acellular Component)
*
Adsorbed Pertussis Vaccine (Acellular, Co-purified)
*
Inactivated Poliomyelitis Vaccine
*
Poliomyelitis Vaccine, Live (Oral)
*
Rabies Vaccine
*
Rotavirus Vaccine (Live, Oral)
*
Rubella Vaccine, Live
*
Shingles (Herpes Zoster) Vaccine (Live)
*
Smallpox Vaccine (Live)
*
Adsorbed Tetanus Vaccine
*
Varicella Vaccine (Live)
*
Yellow Fever Vaccine, Live
*
Old Tuberculin
*
Tuberculin Purified Protein Derivative
*
Radiopharmaceutical Preparations
*
Technetium (<superscript>99m</superscript>Tc) Albumin Injection
*
Technetium (<superscript>99m</superscript>Tc) Colloidal Sulfur
Injection
*
GREY LISTS (MASBOOH): ANIMALS,
HUMAN, INSECTS, OTHERS..3
Technetium (<superscript>99m</superscript>Tc) Colloidal Tin Injection
*
Sterile Catgut
*
Sterile Non-absorbable Sutures
*
Contents of the Appendices
European Pharmacopoeia Equivalent Texts
Plasma Substrate R1
Thromboplastin
Appendix XI D. Foreign Matter
Appendix XIV D. Test for Pyrogens
Appendix XIV E. Test for Abnormal Toxicity
Appendix XIV F. Test for Depressor Substances
Appendix XIV K. Immunological Products
Appendix XV A. Terminology used in Monographs on Biological Products
Appendix XV F. Neurovirulence
Appendix XV J. Cell Substrates for the Production of Vaccines for Human
Use
Appendix XVI B. Microbiological Examination of Non-sterile Products
Appendix XVIII Methods of Sterilisation
Appendix XXII A. Viral Safety
Appendix XXII B. Minimising the Risk of Transmitting Animal Spongiform
Encephalopathy Agents Via Human and Veterinary Medicinal Products
SC I A. Control of Impurities
SC IV C. Certification Scheme
SC IV D. Residual Solvents
SC IV G. 3. Assays depending upon quantitative responses
SC IV J. Control of Impurities in Substances for Pharmaceutical Use
SC IV N. Gene Transfer Medicinal Products for Human Use
SC IV N. RECOMBINANT VECTORS
SC IV N. ADENOVIRUS VECTORS FOR HUMAN USE
SC IV N. POXVIRUS VECTORS FOR HUMAN USE
SC IV N. RETROVIRIDAE-DERIVED VECTORS FOR
HUMAN USE
SC IV N. ADENO-ASSOCIATED-VIRUS VECTORS FOR
HUMAN USE
SC V Unlicensed Medicines
SC VII Traditional Herbal Medicines
Preface
Introduction
Part II
Substances for Pharmaceutical Use
*
Serum Gonadotrophin
*
Veterinary Liquid Preparations for Cutaneous Application
*
Liquid Preparations for Cutaneous Application of the British
Pharmacopoeia (Veterinary)
INTRAMAMMARY INFUSIONS
*
PARENTERAL PREPARATIONS
*
PREMIXES
*
VETERINARY IMMUNOSERA
*
Clostridium Tetani Antitoxin
*
Veterinary Vaccines
*
Anthrax Vaccine, Living
*
Aujeszky's Disease Vaccine, Inactivated
*
Bovine Viral Diarrhoea Vaccine (Inactivated)
*
Calf Coronavirus Diarrhoea Vaccine (Inactivated)
*
Calf Rotavirus Diarrhoea Vaccine (Inactivated)
*
Clostridium Botulinum Vaccine
*
Clostridium Chauvoei Vaccine
*
Clostridium Novyi Type B Vaccine
*
GREY LISTS (MASBOOH): ANIMALS,
HUMAN, INSECTS, OTHERS..4
Clostridium Perfringens Vaccines
*
Clostridium Septicum Vaccine
*
Clostridium Tetani Vaccines
*
Contagious Pustular Dermatitis Vaccine, Living
Equine Herpesvirus Vaccine, Inactivated
*
Feline Chlamydiosis Vaccine (Inactivated)
*
Foot and Mouth Disease (Ruminants) Vaccine
*
Infectious Chicken Anaemia Vaccine (Live)
*
Bovine Leptospirosis Vaccine (Inactivated)
*
Canine Leptospirosis Vaccine (Inactivated)
*
Louping-ill Vaccine
Lungworm (Dictyocaulus Viviparus) Oral Vaccine, Living
Mannheimia Vaccine (Inactivated) for Cattle
*
Mycoplasma Gallisepticum Vaccine (Inactivated)
*
Ovine Enzootic Abortion Vaccine, Inactivated
Porcine Actinobacillosis Vaccine, Inactivated
*
Porcine Enzootic Pneumonia Vaccine (Inactivated)
*
Porcine E. Coli Vaccine, Inactivated
*
Porcine Progressive Atrophic Rhinitis Vaccine, Inactivated
*
Rabies Vaccine for Foxes, Living
*
Rabies Veterinary Vaccine, Inactivated
*
Rabbit Haemorrhagic Disease Vaccine (Inactivated)
*
Ruminant E. Coli Vaccine, Inactivated
*
Salmonella Enteritidis Vaccine (Inactivated) for Chickens
*
Salmonella Typhimurium Vaccine (Inactivated) for Chickens
*
Avian Tuberculin Purified Protein Derivative
*
Bovine Tuberculin Purified Protein Derivative
*
Sterile Non-absorbable Strands in
Distributor
*
Contents
European Pharmacopoeia Equivalent
Texts
Appendix XV A (Vet). Terminology used
in Monographs on Biological Products
Appendix XV J (Vet) 1. Cell Cultures for
the Production of Veterinary Vaccines
Appendix XV J (Vet) 2. Substances of
Animal Origin for the Production of
Immunological Veterinary Medicinal
Products
Appendix XV K (Vet) 1. Evaluation of
Safety of Veterinary Vaccines and
Immunosera
Appendix XV K (Vet) 2. Evaluation of
Efficacy of Veterinary Vaccines and
Immunosera
Appendix XV K (Vet) 3. Evaluation of
Safety of each Batch of Veterinary
Vaccines and Immunosera
*
European
Internationally harmonised
Recombinant DNA
Search: Recombinant DNA, British and European articles only
*
European
Internationally harmonised
Substances for Pharmaceutical Use
*
Allergen Products
*
Alteplase for Injection
*
Calcitonin (Salmon)
*
Erythropoietin Concentrated Solution
*
Products of Fermentation
*
Filgrastim Concentrated Solution
*
Human Glucagon
*
Insulin Aspart
*
Human Insulin
*
Insulin Lispro
*
Interferon Alfa-2 Concentrated Solution
*
Interferon Beta-1a Concentrated Solution
*
Interferon Gamma-1b Concentrated Solution
*
Substances for Pharmaceutical Use
*
Molgramostim Concentrated Solution
*
Products of Recombinant DNA Technology
*
Somatropin
*
Somatropin Concentrated Solution
*
Injectable Insulin Preparations
*
SOMATROPIN FOR INJECTION
*
Dried Factor VIII (rDNA)
*
Monoclonal Antibodies for Human Use
*
Cholera Vaccine (Inactivated, Oral)
*
Diphtheria, Tetanus and Hepatitis B (rDNA) Vaccine
(Adsorbed)
*
Adsorbed Diphtheria, Tetanus, Pertussis (Acellular
Component) and Hepatitis B (rDNA) Vaccine
*
Diphtheria, Tetanus, Pertussis (Acellular,
Component), Hepatitis B (rDNA), Poliomyelitis
(Inactivated) and Haemophilus Type b Conjugate
Vaccine (Adsorbed)
*
Hepatitis A (Inactivated) and Hepatitis B (rDNA)
Vaccine
*
Hepatitis B Vaccine (rDNA)
*
Influenza Vaccine (Whole Virion, Inactivated,
Prepared in Cell Cultures)
*
Influenza Vaccine (Surface Antigen, Inactivated,
Prepared in Cell Cultures)
*
Human Papillomavirus Vaccine (rDNA)
*
Adsorbed Pertussis Vaccine (Acellular Component)
*
Rabies Vaccine
*
Thromboplastin
Appendix III K. Peptide
Mapping<endnotenumber><superscript>1</superscr
ipt></endnotenumber>
Appendix XV J. Cell Substrates for the Production of
Vaccines for Human Use
Substances for Pharmaceutical Use
*
Veterinary Vaccines
*
Feline Leukaemia Vaccine, Inactivated
*
Human insulin
C
257
H
383
N
65
O
77
S
6
5808 11061-
68-0
Action and use
Hormone; treatment of diabetes
mellitus.
Preparations
Insulin Preparations
Ph Eur
DEFINITION
Human insulin is a 2-chain peptide
having the structure of the antidiabetic
hormone produced by the human
pancreas.
Content
95.0 per cent to 105.0 per cent of
human insulin C
257
H
383
N
65
O
77
S
6
plus
A21 desamido human insulin (dried
substance).
By convention, for the purpose of
labelling insulin preparations, 0.0347
mg of human insulin is equivalent to 1
IU of insulin.
PRODUCTION
Human insulin is produced either by
enzymatic modification and suitable
purification of insulin obtained from the
pancreas of the pig or by a method based on
recombinant DNA (rDNA) technology.
Where applicable, the animals from which
human insulin is derived must fulfill the
requirements for the health of animals suitable
for human consumption.
Human insulin is produced under conditions
designed to minimise the degree of microbial
contamination.
For human insulin produced by enzymatic
modification of insulin obtained from the
pancreas of the pig, the manufacturing
process is validated to demonstrate removal
of any residual proteolytic activity. The
competent authority may require additional
tests.
For human insulin produced by a method
based on rDNA technology, prior to release
the following tests are carried out on each
batch of the final bulk product, unless
exemption has been granted by the competent
authority.
Calcitonin (Salmon)
General Notices
(Ph Eur monograph 0471)
C145H240N44O48S2 3432 47931-85-1
Action and use
Hormone.
Preparation
Calcitonin (Salmon) Injection
Ph Eur
DEFINITION
Polypeptide having the structure determined for salmon calcitonin I. It lowers the calcium
concentration in plasma of mammals by diminishing the rate of bone resorption. It is obtained by
chemical synthesis or by a method based on recombinant DNA (rDNA) technology. It is
available as an acetate.
Content
90.0 per cent to 105.0 per cent of the peptide C145H240N44O48S2 (anhydrous and acetic
acidfree
substance).
By convention, for the purpose of labelling calcitonin (salmon) preparations, 1 mg of calcitonin
(salmon) (C145H240N44O48S2) is equivalent to 6000 IU of biological activity.
PRODUCTION
The following requirements apply only to calcitonin (salmon) produced by a method based on
rDNA technology.
Heparin Calcium
General Notices
(Ph Eur monograph 0332)
Action and use
Anticoagulant.
Preparation
Heparin Injection
Ph Eur
DEFINITION
Heparin calcium is a preparation containing the calcium salt of a sulphated glucosaminoglycan present in mammalian tissues. On
complete hydrolysis, it liberates Dglucosamine, D-glucuronic acid, L-iduronic acid, acetic acid and sulphuric acid. It has the
characteristic property of delaying the clotting of freshly shed blood. The potency of heparin calcium intended for parenteral
administration is not less than 150 IU/mg, calculated with reference to the dried substance. The potency of heparin calcium not
intended for parenteral administration is not less than 120 IU/mg, calculated with reference to the dried substance.
PRODUCTION
It is prepared from the lungs of oxen or from the intestinal mucosae of
oxen, pigs or sheep. It is produced by methods of manufacturing designed to minimise or eliminate substances
lowering blood pressure.
CHARACTERS
A white or almost white powder, hygroscopic, freely soluble in water.
IDENTIFICATION
A. It delays the clotting of recalcified citrated sheep plasma (see Assay).
B. Dissolve 0.40 g in water R and dilute to 10.0 ml with the same solvent. The specific optical rotation (2.2.7) is not less than +35.
C. Examine by zone electrophoresis (2.2.31) using agarose for electrophoresis R as the supporting medium. To equilibrate the
agarose and as electrolyte solution use a mixture of 50 ml of glacial acetic acid R and 800 ml of water R adjusted to pH 3 by
addition of lithium hydroxide R and diluted to 1000.0 ml with water R.
Test solutionDissolve 25 mg of the substance to be examined in water R and dilute to 10 ml with the same solvent.
Stearic Acid
General Notices
(Ph Eur monograph 1474)
Action and use
Excipient.
Ph Eur
DEFINITION
Mixture consisting mainly of stearic (octadecanoic) acid
(C18H36O2; M r 284.5) and palmitic (hexadecanoic) acid
(C16H32O2; M r 256.4) obtained from fats or oils of vegetable or
animal origin.
Content
CHARACTERS
Appearance
White or almost white, waxy, flaky crystals, white or almost white hard masses or white
or
yellowish-white powder.
Solubility
Practically insoluble in water, soluble in ethanol (96 per cent) and in light petroleum
(50-70!C).
IDENTIFICATION
Capsules
General Notices
(Ph. Eur. monograph 0016)
Capsules comply with the requirements of the European
Pharmacopoeia. These requirements are reproduced below.
Ph Eur
The requirements of this monograph do not necessarily apply
to preparations that are presented as capsules intended for use
other than by oral administration. Requirements for such
preparations may be found, where appropriate, in other general
monographs, for example Rectal preparations (1145) and Vaginal
preparations (1164).
DEFINITION
Capsules are solid preparations with hard or soft shells of
various shapes and capacities, usually containing a single dose of
active substance(s). They are intended for oral administration.
The capsule shells are made of gelatin or other substances, the
consistency of which may be adjusted by the addition of
substances such as glycerol or sorbitol. Excipients such as
surface-active agents, opaque fillers, antimicrobial preservatives,
sweeteners, colouring matter authorised by the competent
authority and flavouring substances may be added. The capsules
may bear surface markings.
The contents of capsules may be solid, liquid or of a paste-like
consistency. They consist of one or more active substances with
or without excipients such as solvents, diluents, lubricants and
disintegrating agents. The contents do not cause deterioration of
the shell. The shell, however, is attacked by the digestive fluids and
the contents are released.
Where applicable, containers for capsules comply with the
requirements of Materials used for the manufacture of containers
(3.1 and subsections) and Containers (3.2 and subsections).
Several categories of capsules may be distinguished:
hard capsules;
soft capsules;
gastro-resistant capsules;
modified-release capsules;
cachets.
PRODUCTION
In the manufacture, packaging, storage and distribution of
capsules, suitable measures are taken to ensure their microbial
quality; recommendations on this aspect are provided in the text
on Microbiological quality of pharmaceutical preparations (5.1.4).
TESTS
Uniformity of dosage units
Capsules comply with the test for uniformity of dosage units
(2.9.40) or, where justified and authorised, with the tests for
uniformity of content and/or uniformity of mass shown below.
Herbal drugs and herbal drug preparations present in the dosage
form are not subject to the provisions of this paragraph.
Uniformity of content (2.9.6)
Unless otherwise prescribed or justified and authorised, capsules
with a content of active substance less than 2 mg or less than 2
per cent of the fill mass comply with test B for uniformity of
content of single-dose preparations. If the preparation has more
than one active substance, the requirement applies only to those
ingredients which correspond to the above conditions.
Gelatin
(Ph. Eur. monograph 0330)
Action and use
Excipient.
Ph Eur
DEFINITION
Purified protein obtained either by partial
acid hydrolysis (type A), partial alkaline
hydrolysis (type B) or enzymatic hydrolysis of
collagen from animals (including fish and
poultry); it may also be a mixture of different
types.
The hydrolysis leads to gelling or non-gelling product grades.
Both product grades are covered by this monograph.
Gelatin described in this monograph is not suitable for
parenteral administration or for other special purposes.
CHARACTERS
Appearance
Faintly yellow or light yellowish-brown, solid, usually occurring
as translucent sheets, shreds, granules or powder.
Solubility
Practically insoluble in common organic solvents; gelling grades
swell in cold water and give on heating a colloidal solution which
on cooling forms a more or less firm gel.
The isoelectric point is a relevant quality parameter for use of
gelatin in different applications: for type A gelatin it is typically
between pH 6.0 and pH 9.5 and for type B gelatin is typically
between pH 4.7 and pH 5.6. These ranges cover a variety of
different gelatins and for specific applications a narrower
tolerance is usually applied.
Different gelatins form aqueous solutions that vary in clarity and
colour. For a particular application, a suitable specification for
clarity and colour is usually applied.
Practically insoluble in common organic solvents; gelling grades
swell in cold water and give on heating a colloidal solution which on
cooling forms a more or less firm gel.
The isoelectric point is a relevant quality parameter for use of
gelatin in different applications: for type A gelatin it is typically
between pH 6.0 and pH 9.5 and for type B gelatin is typically
between pH 4.7 and pH 5.6. These ranges cover a variety of different
gelatins and for specific applications a narrower tolerance is usually
applied.
Different gelatins form aqueous solutions that vary in clarity and
colour. For a particular application, a suitable specification for clarity
and colour is usually applied.
IDENTIFICATION
A. To 2 mL of solution S (see Tests) add 0.05 mL of copper
sulfate solution R. Mix and add 0.5 mL of dilute sodium hydroxide
solution R. A violet colour is produced.
B. To 0.5 g in a test-tube add 10 mL of water R. Allow to stand for
10 min, heat at 60 !C for 15 min and keep the tube upright at 0 !C for
6 h. Invert the tube; the contents immediately flow out for non-gelling
grades and do not flow out immediately for gelling grades.
TESTS
Solution S
Dissolve 1.00 g in carbon dioxide-free water R at about 55 !C,
dilute to 100 mL with the same solvent and keep the solution at this
temperature to carry out the tests.
pH (2.2.3)
3.8 to 7.6 for solution S.
Conductivity (2.2.38)
WHO Monographs: Pharmaceutical substances:
Gelatina.
Faintly yellow to amber-coloured sheets, flakes, granules,
or powder; practically odourless; in solution it has a slight,
characteristic, bouillon-like odour.Solubility. Practically
insoluble in most organic solvents. In cold water it swells
and softens, absorbing 5-10 times its own mass of water.
After swelling, soluble in hot water, in acetic acid (~300 g/l)
TS, and in a hot mixture of glycerol R and water.Category.
Encapsulating agent; tablet binder; coating agent;
suspending agent; viscosity-increasing agent.Storage.
Gelatin should be kept in a well-closed container.Additional
information. These specifications do not necessarily apply to
gelatin for parenteral use or other particular application.
Attention should be paid to the microbiological quality since
gelatin is of natural origin. Cool the test-tubes and allow
them to stand at 4 C for 24 hours; the type of gelatin is
recognized by the resulting opalescence - a maximum
opalescence appearing at pH 5.0 indicates gelatin type B,
while a maximum opalescence between pH 7.0 and pH 9.0
indicates gelatin type A.
Requirements
Definition. Gelatin is a purified
protein obtained either by the partial
acid hydrolysis (type A) or by the
partial alkali hydrolysis (type B) of
animal collagen. It can exist as a
mixture of both types.
Identity tests A. Dissolve 1 g in carbon-dioxide-free water R, heat to
about 55 C, and dilute to 100 ml with the same solvent. Keep the
solution at this temperature throughout the following test (retain the
solution for test C): to 2 ml add 0.05 ml of copper(II) sulfate (160 g/l)
TS, mix, and add 0.5 ml of sodium hydroxide (~80 g/l) TS; a violet
colour is produced.
B. Transfer 0.5 g to a test-tube, add 10 ml of water, and allow to stand
for 10 minutes. Heat at 60 C for 15 minutes and keep the tube in a
vertical position at 0 C for 6 hours. Invert the tube; the content does
not immediately flow out.C. Acidify 2 ml of the solution prepared for test
A and add 0.5 ml of potassium dichromate (100 g/l) TS; a yellow
precipitate is formed.Heavy metals. Use 1.0 g for the preparation of the
test solution as described under 2.2.3 Limit test for heavy metals,
USP 32 Gelatin
Gelatin is a product obtained by the
partial hydrolysis of collagen derived
from the skin, white connective tissue,
and bones of animals.
Gelatin derived from an acid-treated precursor is known as Type
A, and Gelatin derived from an alkali-treated precursor is known as
Type B.
Gelatin, where being used in the manufacture of capsules, or for
the coating of tablets, may be colored with a certified color, may
contain not more than 0.15 percent of sulfur dioxide, and may
contain a suitable concentration of sodium lauryl sulfate and
suitable antimicrobial agents.
Packaging and storagePreserve in well-closed containers in a
dry place.
IdentificationA: Dissolve 1 g of Gelatin in 100 mL of hot water.
To this solution add about 20 mL of a mixture of 0.2 M potassium
dichromate and 3 N hydrochloric acid (4:1): a yellow precipitate is
formed.
B: To a hot solution (0.2 mg per mL) add tannic acid TS: turbidity is
produced.
Microbial enumeration tests 61 and Tests for specified
microorganisms 62The total bacterial count does not exceed
1000 cfu per g, and the tests for Salmonella species and
Escherichia coli are negative.
Arsenic, Method I 211Pepsin solutionDissolve 0.5 g of
pepsin in 80 mL of 0.1 N hydrochloric acid, dilute with 0.1 N
hydrochloric acid to 100 mL, and mix.
Standard preparationTransfer 3.0 mL of Standard Arsenic
Solution to an arsine generator flask, and dilute with Pepsin
solution to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of
isopropyl alcohol, and mix.
Test preparationMix 3.75 g with 40 mL of Pepsin solution in
an arsine generator flask. Heat cautiously to a temperature
between 65 and 70, and, while maintaining this temperature
for 30 minutes, sonicate the solution for 2 minutes at each 10-
minute interval of heating time. Cool, wash down the sides of
the generator with Pepsin solution, and dilute with Pepsin
solution to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of
isopropyl alcohol, and mix.
ProcedureProceed as directed for Procedure except omit
the addition of 20 mL of 7 N sulfuric acid and 1 mL of isopropyl
alcohol to the Standard preparation and to the Test
preparation. The resulting solution obtained from the Test
preparation meets the requirements of the test: the limit is 0.8
ppm.
Heavy metals 231To the residue obtained in the test for
Residue on ignition add 2 mL of hydrochloric acid and 0.5 mL
of nitric acid, and evaporate on a steam bath to dryness. To
the residue add 1 mL of 1 N hydrochloric acid and 15 mL of
water, and warm for a few minutes. Filter, and wash with water
to make the filtrate measure 100 mL. Dilute 8 mL of the
solution with water to 25 mL: the limit is 0.005%.
Glycerol monostearate
General Notices
(Ph. Eur. monograph 0495)
31566-31-1
Action and use
Excipient.
Ph Eur
DEFINITION
Mixture of monoacylglycerols, mainly
monostearoylglycerol, together with variable
quantities of di- and triacylglycerols. It is obtained
by partial glycerolysis of vegetable oils mainly
containing triacylglycerols of palmitic
(hexadecanoic) or stearic (octadecanoic) acid or by
esterification of glycerol with stearic acid. The fatty
acids may be of vegetable or animal origin.
Content:
monoacylglycerols: 40.0 per cent to 55.0 per cent;
diacylglycerols: 30.0 per cent to 45.0 per cent;
triacylglycerols: 5.0 per cent to 15.0 per cent.
CHARACTERS
Appearance
Hard, waxy mass or unctuous powder or flakes, white or almost
white.
Solubility
Practically insoluble in water, soluble in ethanol (96 per cent) at
60 !C.
IDENTIFICATION
First identification C, D.
Second identification A, B.
A. Melting point (2.2.15): 54 !C to 66 !C.
Introduce the melted substance into the capillary tubes and
allow to stand for 24 h in a well-closed container.
B. Thin-layer chromatography (2.2.27).
Test solution Dissolve 0.5 g of the substance to be examined
in methylene chloride R, with gentle heating, and dilute to 10 mL
with the same solvent.
Reference solution Dissolve 0.5 g of glycerol monostearate
40-55 CRS in methylene chloride R, with gentle heating, and
dilute to 10 mL with the same solvent.
Plate TLC silica gel plate R.
Mobile phase hexane R, ether R (30:70 V/V).
Application 10 L.
Development Over a path of 15 cm.
Detection Spray with a 0.1 g/L solution of rhodamine B R in
ethanol (96 per cent) R and examine in ultraviolet light at 365
nm.
Glycerol monostearate
Suitability system Reference solution:
the chromatogram shows 4 clearly separated spots.
Results The spots in the chromatogram obtained with the
test solution are similar in position to those in the
chromatogram obtained with the reference solution.
C. Composition of fatty acids (see Tests) according to the
type stated on the label.
D. It complies with the limits of the assay
(monoacylglycerol content).
TESTS
Acid value (2.5.1)
Maximum 3.0, determined on 1.0 g.
Use a mixture of equal volumes of ethanol (96 per cent) R
and toluene R as solvent and heat gently.
Iodine value (2.5.4, Method A)
Maximum 3.0.
Saponification value (2.5.6)
158 to 177, determined on 2.0 g. Carry out the titration with
heating.
Free glycerol
Maximum 6.0 per cent, determined as described under
Assay.
Composition of fatty acids (2.4.22, Method C)
Use the mixture of calibrating substances in Table 2.4.22.-1.
Composition of the fatty-acid fraction of the substance:
Nickel (2.4.31)
Maximum 1 ppm.
Water (2.5.12)
Maximum 1.0 per cent, determined on 1.00 g. Use
pyridine R as the solvent and heat gently.
Total ash (2.4.16)
Maximum 0.1 per cent.
Glyceryl Monostearate
Self-emulsifying Monostearin; Self-emulsifying Mono-and
Diglycerides of Food Fatty Acids
Action and use
Excipient.
DEFINITION
Self-emulsifying Glyceryl Monostearate is a mixture consisting
principally of mono-, di- and triglycerides of stearic and palmitic
acids and of minor proportions of glycerides of other fatty acids; it
may also contain free glycerol, free fatty acids and soap. It
contains not less than 30.0% of monoglycerides, calculated as
C
21
H
42
O
4
, not more than 7.0% of free glycerol, calculated as
C
3
H
8
O
3
, and not more than 6.0% of soap, calculated as sodium
oleate, C
18
H
33
NaO
2
, all calculated with reference to the anhydrous
substance.
CHARACTERISTICS
A white to cream coloured, hard, waxy solid.
Dispersible in hot water; soluble in hot absolute ethanol , in hot
liquid paraffin and, subject to turbidity at concentrations below
20%, in hot vegetable oils.
TESTS
Acid value
Not more than 6, Appendix X B.
Iodine value
Not more than 3 (iodine monochloride method), Appendix X E.
Alkalinity
Shake 1 g with 20 mL of hot carbon dioxide-free water and allow
to cool with continuous shaking. The pH of the aqueous layer is
8.0 to 10.0, Appendix V L.
Heavy metals
2.0 g complies with limit test C for heavy metals, Appendix VII.
Use 2 mL of lead standard solution (10 ppm Pb) to prepare the
standard (10 ppm).
Water
Not more than 2.0% w/w, Appendix IX C. Use 0.5 g and a mixture
of 10 mL of anhydrous methanol and 10 mL of anhydrous
chloroform as the solvent.
ASSAY
For free glycerol
Dissolve 0.4 g in 50 mL of dichloromethane in a ground-glass-
stoppered separating funnel, cool if necessary, add 25 mL of water
and shake vigorously for 1 minute; add 0.2 mL of glacial acetic
acid , if necessary, to break the emulsion. Repeat the extraction a
further three times using 25-, 20- and 20- mL quantities of water
and reserve the dichloromethane solution for the Assay for
monoglycerides. Filter the combined aqueous extracts through a
filter paper moistened with water, wash the filter with two 5 mL
quantities of water and dilute the combined filtrate and washings to
100 mL with water. To 50 mL of this solution add 25 mL of periodic
acetic acid solution, shaking cautiously, allow to stand at 25! to
30! for 30 minutes and add 100 mL of water and 12 mL of
potassium iodide solution. Titrate with 0.1M sodium thiosulfate VS
using 1 mL of starch solution as indicator. Repeat the
determination using 50 mL of water in place of the 50 mL of the
solution being examined. The difference between the titrations
represents
CONTENTS
0. Introduction
1. What are the alternative /current pharmaceutical ingredients
available which are considered Halal?
2. What are the opportunities and potential for
pharmaceutical ingredient suppliers to comply with halal
standards?
3. What is the benefit of Halal Index and how can it be used
to increase halal pharmaceutical products?
4. Conclusion
Securing market position
As the bar is raised because of increasing competition and
globalization, local companies will have to produce high-quality
drugs at lower prices to sustain growth.
Membership of Malaysia's Pharmaceutical Inspection
Cooperation Scheme (PICS) helps local firms increase revenues
and maintain market position by increasing their exports to PICS
and non-PICS members, as well as Islamic countries with halal-
certified products and other potential markets, such as
Cambodia and Vietnam.
On example is USM Malaysian-based Finlay-Heber-Bioven Sdn
Bhd, which has teamed up with the Centre for Genetic
Engineering and Biotechnology in Cuba to develop a vaccine for
meningococcal meningitis that will be marketed globally.
Halagel (M) Sdn Bhd has also produced halal pharmaceutical
products such as halal gelatin and halal empty hard gelatin
capsules.
Other potential markets include natural herbal products, which is
projected to reach US$2.5 billion by 2010, and the vitamin and
dietary supplements market, which is the largest contributor to
the country's over the counter sales.
CHALLENGES:
MAPPING THE DRIVERS
RESOURCE halal certified raw materials
TECHNOLOGY-omics platform technologies
PRODUCT- formulation of halal branding/classification,
processing and testing
Suppliers of
Halal Pharmaceuticals
CCM Malaysia
Novartis , Finlay/USM, halal vaccines
Noor Pharmaceuticals
S.I.A Pharma LLC vitamins & nutraceuticals
Merck -Ph Eur - Pharmacopoeial Material
Fortitech Europe
Mallinckrodt
Amin-Bio China
NoorVitamins, a division of Noor
Pharmaceuticals
, specializes in developing high quality Halal vitamins and dietary
supplements for the health-conscious Muslim consumer. Noor
Pharmaceuticals was founded by Muslim physicians and pharmacists, who
experienced first-hand the need for Halal vitamins and nutritional
supplements.
Our mission is to provide the Muslim community with the highest quality Halal
vitamins and supplements in order to promote a healthy and Halal lifestyle.
We are committed to ensuring that our products meet the highest possible
scientific and Halal standards and that our business practices fulfill the
highest Islamic principles.
At NoorVitaminswe certify more than just our vitamins; our US-based
manufacturing facilities are both Halal certified and FDA GMP (Good
Manufacturing Practices) certified. In addition, we observe Halal business
practices, including but not limited to zakat, contracting and financing.
We balance science and Islam in order to provide our consumers Halal
vitamins and nutritional supplements of unsurpassed quality and value. Our
strong commitment to the Muslim community drives us to continue to work on
developing new products and to build partnerships with community
pharmacies so that more Muslims have access to Halal NoorVitamins
S.I.A Pharma LLC
o S.I.A Pharma LLC is dedicated to developing
HALAL Dietary supplement products. The
people behind the company have extensive
experience in the field of Pharmaceutical
Research & Development both in the
Pharmaceutical industry and the Dietary
Supplement industry.
o HalViTAdult Multivitamin, is a Complete
(from Vitamin A to Zinc) Multivitamin
Multimineral Brand with LUTEIN &
LYCOPENE, in the retail market, CERTIFIED
HALAL by IFANCA (Islamic Food & Nutrition
Council of America, http://www.ifanca.org)
and carries their Halal certification symbol,
Crescent M.
o HalViTbrand was launched with an Adult
Multivitamin Multimineral Dietary Supplement
product, which is comparable in nutritional
value to any leading multivitamin brand.
o In the second phase, a tasty
Childrens Chewable Multivitamin
Multimineral product HalViTJ r,
was launched.
o SIA Pharma has several dietary
supplement products in its
Research & Development (R&D)
pipeline and will be launching
those in the next several phases.
Focus primarily will be on
products For Men and For
Women tailored for performance
and special dietary and
physiological needs for Him &
Her.
Merck Ph Europe
Pharmacopoeia Materials
Material "Ph Eur intended for pharmaceutical production
Analytical part with Mercks high level QC
Production according to cGMP status
Documentation according to current guidelines
Allowing cGMP/customer audits
Providing certificates
Allergenes, Aflatoxins, BSE/TSE, GMO, Residual Solvents
Kosher, Halal, manufacturing procedures
Validation of process parameters
control of raw materials used in the production
control of facilities and equipment
Fortitech sets sights on Halal market
By Jess Halliday
24/04/2006 - Fortitech Europe is looking to increase customers and
confidence in its nutrient premixes by having its Danish manufacturing
and testing facility certified Halal-compliant.
The worldwide Muslim population tops 1.5 billion, and Fortitech Europe's
move is partly an effort to deliver food, beverage and pharmaceutical
products that tap into this market.
But managing director Peter Srensen said: "Meeting the rigorous Halal
requirements is an excellent move for Fortitech's growing business initiatives
in our market."
He drew attention to the quality and safety assurance that a Halal guarantee
provides, which may increase confidence in products for a diverse group of
consumers, not just Muslims.
Mallinckrodt
Stearates
Over 20 billion OTC and prescription tablets are manufactured using
Mallinckrodt stearates annually. Mallinckrodt stearates are sold
throughout the world including North America, Asia, Europe, Latin
America, and the Middle East. In addition to pharmaceutical
applications, our stearates are critical ingredients in food, plastic
processing, and specialized industrial coatings.
We offer a wide variety of stearates from three families: magnesium,
calcium, and aluminum. We offer Kosher and Halal certified products
and a variety of package sizes including bags, drums, cases, or
supersacks. Our stearates meet the worldwide compendia of NF, EP,
BP, and JP, plus we report results on critical physical parameters
including sieve, particle diameter, surface area, and density.
Securing market position
China!s intention to be Global leader in halal
pharmaceuticals
Shanghai Al-Amin Biotech Co. Ltd
Halal raw materials (gelatine, collagen, chondroitin Sulfate,
glocosamine)
Halal enzyme (rennin)
Halal Biopharmaceuticals (heparin, chymotrypsin,
hyaluronidase, trypsin, pancreatin)
CONTENTS
0. Introduction
1. What are the opportunities and potential for
pharmaceutical ingredient suppliers to comply with
halal standards?
2. What are the alternative /current pharmaceutical
ingredients available which are considered Halal?
3.What is the benefit of Halal Index and how can it
be used to increase halal pharmaceutical products?
4.Conclusion
Pharmaceuticals from pig source
Adrenal Glands
Corticosteroids
Cortisone
Epinephrine
Norepinephrine
Blood
Blood Albumens
Blood Fibrin
Fetal Pig Plasma
Plasmin
Brain
Cholesterol
Hypothalamus
Gall Bladder
Chenodeoxycholic Acid
Heart
Heart Valves
Intestines
Enterogastrone
Heparin
Secretin
Liver
Cholic Acid Catalase
Desiccated Liver
Ovaries
Estrogen
Progesterone
Relaxin
Pancreas Gland
Insulin
Kallikrein
Glucagon
Lipase
Pancreatin
Trypsin
Chymotrypsin
Pineal Gland
Melatonin
Pituitary Gland
ACTH Adrenocorticotropic Hormone
ADH Antidiuretic Hormone
Oxytocin
Prolactin
TSH Thyroid Stimulating Hormone
Skin
Porcine Burn Dressing
Gelatin
Spleen
Splenic Fluid
Stomach
Pepsin
Mucin
Intrinsic Factor
Thyroid Gland
Thyroxin
Calcitonin
Thyrogloblin
THE
MALAY
MAIL
JANUARY
13, 1989
Anticoagulant Agents
Vitamin K antagonists
(inhibit II, VII, IX, X)
coumarins:
Acenocoumarol
Coumatetralyl Dicoumarol
Ethyl biscoumacetate
Phenprocoumon
Warfarin
#
1,3-Indandiones:
Clorindione Diphenadione Phenindione
other: Tioclomarol
Factor Xa
inhibitors
(with some II
inhibition)
Heparin group/
glycosaminoglyca
ns/
(bind
antithrombin)
Low molecular weight heparin ;
Bemiparin Certoparin Dalteparin
Enoxaparin Nadroparin Parnaparin
Reviparin Tinzaparin
Oligosaccharides
Fondaparinux Idraparinux
Heparinoid
Danaparoid Dermatan sulfate
Sulodexide
Direct Xa inhibitors xabans
Apixaban Betrixaban Edoxaban Otamixaban
Rivaroxaban
Direct thrombin (II)
inhibitors
bivalent:
Hirudin .Bivalirudin
Desirudin Lepirudin
univalent:
Argatroban Dabigatran Melagatran
Ximelagatran